This invention relates to kits for the delivery of restorative compositions into an intraosseous space, especially kits, usable in percutaneous surgical procedures, such as percutaneous vertebroplasty. This invention is also directed to systems for the delivery of aliquots of restorative compositions into a desired space especially via catheters. The kits may further comprise needles/cannulae, stylets/mandarins and/or syringes.
Percutaneous surgical procedures have come to the forefront of the orthopaedic and neurological surgery fields, in an effort to limit exposure of tissues, reduce operating time, speed up recovery time and minimize patient scarring. Percutaneous vertebroplasty is a procedure by which, currently, acrylic cement, typically polymethylmethacrylate (xe2x80x9cPMMAxe2x80x9d), is injected into the vertebral body by a percutaneous route in order to prevent vertebral body collapse and pain in patients with unhealthy vertebral bodies. Percutaneous injection has been indicated as a means of pain relief and restoration in patients with vertebral hemangiomas, painful vertebral body tumors, as well as painful osteoporosis with loss of height and/or compression fractures of the vertebral body. See, e.g., Gangi, A., et al. Percutaneous Vertebroplasty Guided by a Combination of CT and Fluoroscopy, AJNR 15:83-86, January 1994 (xe2x80x9cGangixe2x80x9d). All references cited in this specification are incorporated herein by reference. Percutaneous injection is also minimally invasive compared to the alternative of exposing the entire soft and hard tissue at the surgical site.
U.S. Pat. Nos. 6,033,411 and 6,019,776 to Preissman, et al. disclose methods for controlled approach to the interior of a vertebral body by inserting a threaded or sharp-pointed mandarin and cannula percutaneously through the soft tissue of an organism until abutting the soft tissue; further inserting the mandarin into a predetermined location within the hard tissue; ratcheting a pawl mechanism or rotating a camming mechanism to advance the cannula along the mandarin to the predetermined location; withdrawing the mandarin from the cannula and attaching a source of implantable material for injection of the material into the organism through the cannula.
U.S. Pat. No. 4,838,282 to Strasser, et al. (xe2x80x9cStrasserxe2x80x9d) discloses a bone biopsy needle assembly for withdrawing samples of bone, bone marrow and other such fluids, which includes a cannula and stylet. The handles of the cannula and stylet are provided with features for mating reception when assembled together. In addition, both the cannula and stylet handles are comprised of two equal generally rectangular halves extending in diametrically opposed directions from the cannula axis.
U.S. Pat. No. 4,793,363 to Ausherman, et al. (xe2x80x9cAushermanxe2x80x9d) discloses a bone marrow biopsy device that includes a cannula member and a stylet member with a Luer-lock connector and handle locking arrangement.
U.S. Pat. No. 4,469,109 to Mehl (xe2x80x9cMehlxe2x80x9d) discloses a bone marrow aspiration needle including a cannula, with a cannula housing which supports the cannula, and a partially threaded lower member, and a stylet, with a stylet cap which supports the stylet and a threaded depth stop for engaging over the cannula.
U.S. Pat. No. 5,601,559 to Melker, et al. (xe2x80x9cMelkerxe2x80x9d) discloses an intraosseous needle having a threaded shaft with two side ports, which allow fluids to pass through the needle, and a tip having a plurality of cutting edges.
Heini, P. F. et al., Percutaneous Transpedicular Vertebroplasty with PMMA: Operative Technique and Early Results: A Prospective Study for the Treatment of Osteoporotic Compression Fractures, Eur.Spine J. (2000) 9:445-450 (xe2x80x9cHeinixe2x80x9d), discusses the use of various components for performing percutaneous transpedicular vertebroplasty including a 2.0 mm K-wire for accessing the center of the vertebral body and a bone marrow biopsy needle placed over the K-wire (which is subsequently removed) for positioning the needle. Heini also discloses the use of 2-cc standard syringes for injecting the material through the needle.
Gangi describes the percutaneous injection of PMMA into the vertebral body with the aid of CT and/or fluoroscopic guidance using a needle and 2-ml Luer-lock syringe mounted on a pressure regulator to facilitate the injection of the material.
Chiras, J., et al., Percutaneous Vertebroplasty, J Neuroradiol, 1997, 24, 45-59 (xe2x80x9cChirasxe2x80x9d) discloses cannulae of 10 to 15 cm in length with a beveled edge lumen and diameter of 3 mm as being standard equipment for vertebroplasty.
Deramond, H., et al., Percutaneous Vertebroplasty, Seminars In Musculoskeletal Radiology, Vol. 1, No. 2, 1997: 285-295 (xe2x80x9cDeramondxe2x80x9d), discloses the use of various materials for percutaneous vertebroplasty (xe2x80x9cPVPxe2x80x9d) including ten-gauge needles, 10 to 15 cm long, with a beveled extremity, fifteen-gauge needles, 5 to 7 cm long, with a tapered tip, Luer-lock syringes of 2 or 3 cc, a syringe handle and bone cement. Deramond suggests that leakage can be avoided by making injections under lateral fluoroscopic control or inserting the cannula into the lateral part of the vertebral body.
Jensen, M. E., et al., Percutaneous Polymethylmethacrylate Vertebroplasty in the Treatment of Osteoporotic Vertebral Body Compression Fractures: Technical Aspects, AJNR 18:1897-1904, November 1997 (xe2x80x9cJensenxe2x80x9d) discusses the use of various components for performing vertebroplasty procedures including a disposable 11-gauge Jamshidi needle and stylet for accessing a desired space, and both 10-ml and 1-ml syringes and an 18-gauge needle for the injection of material through the needle. Jensen, et al. teaches that the material should be allowed to set only if a leak should occur.
In the art, if a leak is detected, the operator either stops the procedure altogether, continues with the injection of more material using a different xe2x80x9cbatchxe2x80x9d of material, or allows the material that already has been injected to thicken Clinically, using a different xe2x80x9cbatchxe2x80x9d of material requires the surgeon to open another xe2x80x9cbatchxe2x80x9d of material, which is costly and not desirable or practical in the case of standard restorative materials such as PMMA. Often in the case of a leak, the surgeon does not allow the material to set, but rather waits until the material reaches a pasty stage (thicken) prior to injecting more material. This approach, however, prevents the surgeon from injecting the desired amount of material, since once the material becomes pasty, he has little time to work and must forcefully inject additional material prior to the material setting in the cannula. If the material hardens in the cannula, the cannula will have to be removed and reinserted for additional doses. Surgeons are very skeptical about doing this because of the extreme difficulty in reinserting another cannula in the same exact place as the one removed.
Accordingly, it is the principle object of this invention to provide kits for minimally invasive delivery of restorative composition into an intraosseous space.
Additional objects, advantages and novel features of this invention will become apparent to those skilled in the art upon examination of the following descriptions, figures and claims thereof, which are not intended to be limiting.
This invention relates to device combinations and packaged kits for the delivery of a restorative composition into an intraosseous space. These comprise one or more cannulae adapted for accessing said intraosseous space; one or more stylets/mandarins insertable into the hollow cavity of the cannula and being movable therein to advance the cannula into position. These are adapted for accessing said intraosseous space. The kits and systems preferably also have one or more catheters that are insertable into the cannulae; and a system for delivery of aliquots of said restorative composition into the intraosseous space via the catheters. The kits can also include a micro-reamer that fits within the hollow cavity of the cannula (after removal of the stylet and before insertion of the catheter) to make a channel for material delivery via the catheter. Fixed to the proximate end of each of the cannulae, stylet, and micro-reamer is a substantially lateral surface (flat, solid knob or pedestal) responsive to impact blows. The cannula, micro-reamer and catheter may also include gradations.
The catheters of the present invention have a distal end and at least one placement orifice disposed proximate to the distal end, wherein the placement orifice may be adapted for dispensing the restorative composition directly from the distal end or radially therefrom. Catheters used in the kits may comprise stainless steel, polyimide, latex, silicone, vinyl, or polymers other than those listed herein. They may be flexible for maneuverability and be long and of such material that they can be cut to size at the time of use.
The kits can preferably further comprise a plurality of syringes having an aperture on a distal end providing fluidic passage therethrough from a bore being engageable within said aperture; as well as a locking mechanism, such as a Luer-lock type of locking mechanism, for engaging a proximal end of the catheter for dispensing of the material into the space through the catheter. In a preferred embodiment, the kit includes a plurality of syringes including a 1 cc, 3 cc and 5 cc syringes.
This invention also relates to a system for the delivery of a restorative composition to specific intraosseous space wherein the placement of aliquots of said restorative composition is under tactile feedback control of a human operator, such as a surgeon or interventionalist. The restorative composition can comprise a hydrogel, synthetic bone void filler, polymethylmethacrylate, or replicated bone marrow.